BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3963758 · Received July 29, 2014

    Report

    Report Number
    3005099803-2014-02622
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE TO THE LEFT LOWER LOBES OF THE LUNG ON (B)(6) 2014. THE PROCEDURE ¿WENT FINE¿ AND THE PATIENT WAS ¿FINE¿ FOLLOWING THE PROCEDURE AND WAS DISCHARGED. REPORTEDLY, THERE WERE NO MALFUNCTIONS WITH THE DEVICE. ON (B)(6) 2014, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO AN ASTHMA EXACERBATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL (DATE UNKNOWN). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441420 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization